PASSReviewer 1· 85% conf
Core design elements are well reported: placebo-controlled double-blind randomization, stratified allocation, predefined inclusion/exclusion, power calculation, and missing-data handling. Randomization method (e.g., RNG, block) is not explicitly stated.
Evidence
direct quote[Methods, Trial Design, Population, and Procedures]
“Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods, Statistical Analyses]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”direct quote[Table 2 footnote]
“missing data at week 12 following treatment discontinuation were imputed using a multiple imputation retrieved dropout method and missing data at week 12 following initiation of rescue medication were imputed using a multiple imputation washout method.”PASSReviewer 2· 85% conf
A well-designed phase 3 RCT with a priori power calculation, double-blinding, pre-specified inclusion/exclusion criteria, and explicit missing-data handling; the specific randomization generation method is not detailed.
Evidence
direct quote[Methods, Statistical Analyses]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”direct quote[Methods, Trial Design]
“Participants were randomly assigned 1:1:1 to receive baxdrostat 1 mg, baxdrostat 2 mg, or placebo once daily. Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods and Table 2 footnote]
“missing data at week 12 following treatment discontinuation were imputed using a multiple imputation retrieved dropout method and missing data at week 12 following initiation of rescue medication were imputed using a multiple imputation washout method.”PASSReviewer 3· 92% conf
The study design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analysis methods, though the randomization method itself is not explicitly stated.
Evidence
direct quote[Methods, paragraph 4]
“Participants were randomly assigned 1:1:1 to receive baxdrostat 1 mg, baxdrostat 2 mg, or placebo once daily. Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods, paragraph 8]
“Part 1 was a 12-week double-blind, randomized, placebo-controlled period, forming the basis of the primary outcome reported here.”direct quote[Statistical Analyses, paragraph 2]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”